阿托伐他汀联合依折麦布治疗老年冠心病或急性冠脉综合征的有效性与安全性Meta分析

目的系统评价阿托伐他汀联合依折麦布治疗老年冠心病(CHD)或急性冠脉综合征(ACS)的有效性和安全性,为临床提供循证参考。方法计算机检索PubMed、EMbase、The Cochrane Library、中国知网(CNKI)、CBM、VIP、Wanfang数据库,收集阿托伐他汀联合依折麦布相比单用中高强度阿托伐他汀治疗老年CHD或ACS的随机对照试验(RCT),提取资料,并按Cochrane系统评价员手册5.1.0评价质量后,采用RevMan 5.3统计软件对数据进行Meta分析。结果最终纳入6项RCTs,包括1720例患者。Meta分析结果显示,阿托伐他汀联合依折麦布对低密度脂蛋白胆固醇(LDL-C)的降低效果好于单用中高强度阿托伐他汀MD=-5.83,95%CI(-11.01,-0.64),P=0.03];亚组分析中,对于老年ACS患者,阿托伐他汀联合依折麦布对LDL-C的降低效果与单用中高强度阿托伐他汀相当MD=1.85,95%CI(-13.83,17.52),P=0.82];对于仅提示CHD或CHD高风险老年患者,阿托伐他汀联合依折麦布对LDL-C的降低效果好于单用中高强度阿托伐他汀MD=-8.72,95%CI(-13.21,-4.23),P=0.0001]。对于老年ACS患者,阿托伐他汀联合依折麦布治疗后的LDL-C达标率显著高于单用中高强度阿托伐他汀OR=0.68,95%CI(0.53,0.86),P=0.001]。对于仅提示CHD或CHD高风险老年患者,阿托伐他汀联合依折麦布治疗后不良反应发生率和单用中高强度阿托伐他汀无显著差异OR=0.97,95%CI(0.59,1.58),P=0.89];对于ACS老年患者,阿托伐他汀联合依折麦布与单用中高强度阿托伐他汀治疗后主要心血管不良事件发生率无显著差异OR=1.27,95%CI(0.78,2.08),P=0.34];阿托伐他汀联合依折麦布和单用中高强度阿托伐他汀治疗后丙氨酸氨基转移酶(ALT)升高至正常值3倍以上的患者数无显著差异OR=0.29,95%CI(0.07,1.21),P=0.09]。结论对于60岁以上患有CHD或CHD高风险的老年患者,阿托伐他汀联合依折麦布降低LDL-C的效果好于单用中高强度的阿托伐他汀;对于老年ACS患者,两种治疗方案的有效性无显著差异。两种治疗方案不良反应无明显差异。

Efficacy and Safety of Atorvastatin Combined with Ezetimibe in the Treatment of Elderly Patients with Coronary Heart Disease or Acute Coronary Syndrome:A Meta-Analysis

Objective To systematically review the efficacy and safety of atorvastatin combined with ezetimibe in the treatment of elderly patients with coronary heart disease(CHD)or acute coronary syndrome(ACS),and to provide an evidence-based reference for clinical practice.Methods PubMed,Embase,The Cochrane Library,CNKI,CBM,VIP and Wanfang databases were electronically searched to collect the randomized controlled trials(RCTs)about atorvastatin combined with ezetimibe versus medium-high dose atorvastatin in the treatment of elderly patients with CHD or ACS.The data were extracted and assessed according to the Cochrane Reviewers’Handbook5.1.0.The Meta-analysis was performed by using Revman 5.3 software.Results Six RCTs involving 1720 patients were included.The results of Meta-analysis showed that the effect of atorvastatin combined with ezetimibe on reducing low-density lipoprotein cholesterol(LDL-C)was better than that of medium-high dose atorvastatin aloneMD=-5.83,95%CI(-11.01,-0.64),P=0.03].In subgroups,the effect of atorvastatin combined with ezetimibe on reducing LDL-C in elderly patients with ACS was similar to that of medium-high dose atorvastatin aloneMD=1.85,95%CI(-13.83,17.52),P=0.82],the effect of atorvastatin combined with ezetimibe on reducing LDL-C in patients with only CHD or high risk of CHD was better than that of medium-high dose atorvastatin aloneMD=-8.72,95%CI(-13.21,-4.23),P=0.0001].The LDL-C compliance rate of elderly patients with ACS treated with atorvastatin combined with ezetimibe was significantly higher than that of patients treated with medium-high dose atorvastatin aloneOR=0.68,95%CI(0.53,0.86),P=0.001].There was no significant difference in the incidence of adverse drug reactions in elderly patients with only CHD or high risk of CHD between atorvastatin combined with ezetimibe and medium-high dose atorvastatin aloneOR=0.97,95%CI(0.59,1.58),P=0.89],also no significant difference in the incidence of major adverse cardiovascular events(MACE)in elderly patients with ACSOR=1.27,95%CI(0.78,2.08),P=0.34].After administration of atorvastatin combined with ezetimibe or medium-high dose atorvastatin alone,there was no significant difference in the number of patients whose alanine aminotransferase(ALT)increased more than 3-foldOR=0.29,95%CI(0.07,1.21),P=0.09].Conclusion For elderly patients over 60 years old with CHD or high risk of CHD,atorvastatin combined with ezetimibe had a better effect of reducing LDL-C than medium-high dose atorvastatin alone.For elderly patients with ACS,there is no significant difference in clinical efficacy between the two treatment plans.There was no significant difference in adverse drug reactions between the two treatment plans.